Medical Director (Global Clinical Development) (m/f/d)
📍 Location: Europe, UK or US East Coast
🕒 Start: As soon as possible
📄 Employment type: Full-time, permanent
About Us
Pentixapharm AG is a research-driven radiopharmaceutical and precision oncology company focused on developing innovative theranostic therapies. Our clinical-stage programs target the CXCR4 receptor, which plays a key role in aggressive hematologic and solid tumors as well as cardiovascular diseases. We operate in a lean, science-driven biotech environment with a strong focus on execution and accountability.
The Role
We are looking for an experienced Medical Director (Global Clinical Development) to lead the overall medical and clinical strategy for our late-stage development programs, with a strong focus on diagnostic imaging and radiopharmaceutical development.
This role combines strategic leadership with hands-on execution across pivotal clinical trials, regulatory interactions, and benefit–risk assessment in a highly matrixed biotech environment.
Key Responsibilities
* Lead overall medical and clinical strategy for late-stage (Phase 2/3 and Phase 3 pivotal) development programs
* Provide medical leadership for clinical trial design and execution, including diagnostic and therapeutic radiopharmaceutical studies
* Author and review clinical protocols, Clinical IND sections, SAP-relevant sections, and Clinical Study Reports (CSRs)
* Oversee benefit–risk assessment and interpretation of diagnostic and imaging performance data
* Lead interactions with FDA and EMA, including preparation of briefing books and regulatory responses
* Collaborate closely with Regulatory Affairs, Clinical Operations, Biostatistics, Translational Research, and external partners
* Provide medical input to development strategy, endpoints, and go/no-go decisions
Your Profile
* MD (or equivalent medical degree); background in Radio/Nuclear Medicine or diagnostic imaging strongly preferred
* Substantial experience in diagnostic imaging, ideally including PET/CT and molecular imaging
* Proven experience leading late-stage oncology or diagnostic development programs
* Strong understanding of clinical trial methodology, regulatory expectations, and registrational strategy
* Demonstrated direct engagement with FDA and EMA
* Ability to combine high-level strategic thinking with hands-on execution
* Comfortable working in a lean biotech environment with high accountability
* Fluency in English; German is a plus
Why Join Us
* High-impact leadership role with strategic ownership of late-stage global programs
* Science-driven, collaborative biotech culture with flat hierarchies
* Flexible, hybrid working model (Europe or US East Coast)